Label: ALPHA FOAMING E-2- benzalkonium chloride soap

  • NDC Code(s): 65585-514-01, 65585-514-02
  • Packager: Whisk Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 28, 2020

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  • ​Active Ingredient

    Benzalkonium Chloride 0.1%

  • ​Purpose

    Skin Antimicrobial

  • Uses

    • Reduces amount of bacteria on hands
    • Recommended for repeated use

  • ​Warnings

    For external use only.

    When using this product, avoid contact with eyes.  In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • ​Directions

    • Pump a small amount of foam into palm of hand.
    • Rub thoroughly over all surfaces of both hands for at least fifteen seconds.
    • Rinse with potable water.
  • ​Inactive Ingredients

    Water, Lauramine Oxide, Glycerin, PEG-120 Methyl Glucose Dioleate

  • PRINCIPAL DISPLAY PANEL

    Case Label, 8 x 1000 mL Bags

  • INGREDIENTS AND APPEARANCE
    ALPHA FOAMING E-2 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65585-514
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Colorwhite (colorless, water-white (dispensed as a white foam)) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65585-514-014 in 1 BOX04/23/2020
    11000 mL in 1 BAG; Type 0: Not a Combination Product
    2NDC:65585-514-028 in 1 BOX04/23/2020
    21000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/23/2020
    Labeler - Whisk Products, Inc. (834270639)
    Establishment
    NameAddressID/FEIBusiness Operations
    Whisk Products, Inc.834270639manufacture(65585-514)
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